MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-14 for AWL N/A 72.00.35 manufactured by Zimmer Gmbh.
[57812160]
The manufacturer did not receive the device for review. X-ray pictures were received and will be reviewed within the investigation. A lot number was received for the device, the device history records will be reviewed within the investigation. A cause for this specific event cannot be ascertained from the information provided. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57812161]
It was reported that during surgery, the awl broke in two. One part was left in the patient.
Patient Sequence No: 1, Text Type: D, B5
[66165282]
A technical investigation was not possible to perform, as the devices were not at hand. However, based on the available information the investigation is conducted with outcome as follows. Trend analysis: no trend identified. Device history records (dhr): at zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures. Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold. These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors. Thus, for all products sold to the market can be assumed having a complete and correct dhr. Event summary: it is reported that the "handawl for reaming ms 30" broke in two parts, one part is left in the patient. Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received. Devices analysis: no product was returned to zimmer biomet for in-depth analysis. Review of product documentation: parts were 100% visually inspected (in the year 1998). Conclusion summary: cutting and drilling instruments are categorized as? External communicating devices? With "tissue/bone" contact for less than 24 hours. Due to the fact that a part of the instrument stayed in the body, patient has to be monitored. The instrument was in use for around 18 years. Therefore the most likely root cause is that the function of the blades was not given anymore due to long term use / excessive use (wear). Additionally, according to the ifu: "if damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for replacement. " however, an exact root cause could not be determined. The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0009613350-2016-01265 |
| MDR Report Key | 6029496 |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 1998-12-22 |
| Date Added to Maude | 2016-10-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN ESCAPULE |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-10-14 |
| Model Number | N/A |
| Catalog Number | 72.00.35 |
| Lot Number | 9207 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-14 |